Appendix 5 - Operator's or Canadian Food Inspection Agency's procedure when Category 2 product(s) are tested for Listeria monocytogenes.

This flow chart lists the steps to be followed when Category 2A or 2B product is tested for Listeria monocytogenes.

Two options exist for testing of Category 2 products for Listeria monocytogenes. Option one is direct enumeration of Listeria monocytogenes while option two is detection of Listeria monocytogenes.

Using Option 1:

Five subunits are enumerated for Listeria monocytogenes individually. Three options exist when looking at these results:

• Satisfactory - No result is equal to or greater than 100 Colony Forming Units/gram and not more than one result falls between 50 and 100 Colony Forming Units/gram
• Investigative - No result is equal to or greater than 100 Colony Forming Units/gram and two or more results fall between 50 and 100 Colony Forming Units/gram
• Unsatisfactory - Any result is greater than 100 Colony Forming Units/gram

Product with satisfactory results may be released.

When results are investigative, processing and other parameters must be verified to ensure the product classification is correct. Follow up testing (enumeration) is required immediately after notification. If this follow up testing is satisfactory, product may be released. If it is unsatisfactory or investigative, follow up must ensue following the unsatisfactory model.

When results are unsatisfactory, Canadian Food Inspection Agency issues a Corrective Action Request, the operator initiates corrective actions including intensive sanitation and cleaning, reviewing appropriate sections of their Hazard Analysis and Critical Control Point plan as well as verifying processing and other parameters used for classification of their product. A health risk assessment will be obtained from the Area Program Specialist to determine product disposition. A modified hold-and-test procedure must be implemented as described in Appendix 7.

If product is negative for Listeria monocytogenes during the modified hold-and-test procedure, it can be released.

If product that is on modified hold-and-test is positive for Listeria monocytogenes, the modified hold-and-test must be restarted from the beginning. Additionally, the operator will perform corrective actions including intensive sanitation and cleaning, a review of appropriate sections of the Hazard Analysis and Critical Control Point system, and verification of their processing parameters. A health risk assessment will be obtained from the Area Program Specialist to determine product disposition.

Using Option 2:

As an alternative to direct enumeration of Listeria monocytogenes, the operator may choose to use a detection method. If Listeria monocytogenes is not detected in the product, it may be released.

If Listeria monocytogenes is detected in the product, it must then be enumerated and handled according to option 1.

Notes:

• Modified hold-and-test is also used for Category 1 product produced on non-dedicated lines. If this Category 1 product tests positive for Listeria monocytogenes, regular hold-and-test must resume on this product as per Appendix 7
• Products for export must meet the importing country's requirements
• If any subunits are positive for Listeria monocytogenes and the product is destined for high risk population groups, a Health Risk Assessment is always required to release the product.